Toripalimab Combined With Double Platinum Based Chemotherapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer

August 12, 2023 updated by: Yongchang Zhang

A Phase II Study on Toripalimab Combined With Double Platinum Based Chemotherapy for as a Neoadjuvant Therapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer

The aim of the study was to investigate the safety and efficacy of Toripalimab Combined With Double Platinum Based Chemotherapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Provincal Tumor Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Previously untreated, histologically confirmed potentially resectable stage IIIA or IIIB (AJCC staging eighth edition) NSCLC; potentially resectable refers to a discussion by the surgeon, including primary T3 or T4, mediastinum Lymph node metastasis (N2) is defined as: single-site or multi-station metastasis can be confirmed by imaging or pathology with a short diameter ≥ 2 cm, and it is expected that resection is difficult or pneumonectomy is required;
  2. Before the enrollment, submit the PD-L1 immunohistochemistry section and the corresponding pathology report for biomarker evaluation (the tumor tissue sample must be fresh or archived samples obtained within 3 months before enrollment; Fresh tissue must be a needle biopsy, excision or incision biopsy specimen);

Exclusion Criteria:

Patients received Toripalimab before Patients with contraindication of chemotherapy Pregnant or breast feeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Toripalimab Combined With Platinum-containing Dual-agent
Toripalimab combined with platinum-containing dual-agent as a neoadjuvant Therapy for Non-small Cell Lung Cancer
Drug: Toripalimab combination with platinum-containing dual-drug chemotherapy
Nab-paclitaxel/pem +cisplatin +PD-1(Nab-paclitaxel260mg/m2 D1 Cisplatin 75mg/m2 D1 or carboplatin,determined by the investigator AUC)PD-1 200mg D1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 surgical resection rate
Time Frame: Approximately 1 years
No residual ratio under the microscope after surgical resection
Approximately 1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: Approximately 1 years
To measure the patients's overall response rate
Approximately 1 years
MPR
Time Frame: Approximately 1 years
Neoadjuvant therapy-induced tumor regression in pathologically residual tumors <10%
Approximately 1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yongchang Zhang

Investigators

  • Principal Investigator: Yongchang Z MD, MD, Hunan Province Tumor Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2019

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

July 30, 2023

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 12, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOGATHER

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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